Trial Outcomes & Findings for Nitric Oxide to Treat Pulmonary Embolism (NCT NCT01939301)

NCT ID: NCT01939301

Last Updated: 2018-10-03

Results Overview

Right ventricular (RV) function and viability assessed by the composite of normal RV size (\<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) \> 16 mm and normal right ventricular index of myocardial performance (RIMP) \< 0.40 using spectral Doppler or \< 0.55 using tissue Doppler) and normal fractional area change (FAC) (\> 33%) and a serum hsTnT \< 14pg/mL. Missing values will be considered normal.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 78 participants
• Primary outcome timeframe: 5 days or hospital discharge (whichever occurs first)
• Results posted on: 2018-10-03

Participant Flow

Participant milestones

Measure	Inhaled Nitric Oxide Inhaled nitric oxide Nitric Oxide + oxygen	Sham oxygen Nitrogen + Oxygen
Overall Study STARTED	39	39
Overall Study COMPLETED	38	38
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitric Oxide to Treat Pulmonary Embolism

Baseline characteristics by cohort

Measure	Inhaled Nitric Oxide n=39 Participants Inhaled nitric oxide Nitric Oxide + oxygen	Sham n=39 Participants oxygen Nitrogen + Oxygen	Total n=78 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 15 • n=5 Participants	59 years STANDARD_DEVIATION 16 • n=7 Participants	57 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days or hospital discharge (whichever occurs first)

Right ventricular (RV) function and viability assessed by the composite of normal RV size (<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) > 16 mm and normal right ventricular index of myocardial performance (RIMP) < 0.40 using spectral Doppler or < 0.55 using tissue Doppler) and normal fractional area change (FAC) (> 33%) and a serum hsTnT < 14pg/mL. Missing values will be considered normal.

Outcome measures

Measure	Inhaled Nitric Oxide n=38 Participants Inhaled nitric oxide Nitric Oxide + oxygen	Sham n=38 Participants oxygen Nitrogen + Oxygen
Number of Participants With Normal Right Ventricular (RV) Function and Viability	9 Participants	5 Participants

Adverse Events

Inhaled Nitric Oxide

Serious events: 2 serious events

Other events: 12 other events

Deaths: 2 deaths

Sham

Serious events: 2 serious events

Other events: 11 other events

Deaths: 2 deaths

Serious adverse events

Measure	Inhaled Nitric Oxide n=38 participants at risk Inhaled nitric oxide Nitric Oxide + oxygen	Sham n=38 participants at risk oxygen Nitrogen + Oxygen
Respiratory, thoracic and mediastinal disorders death	5.3% 2/38 • Number of events 2 • 28 days	5.3% 2/38 • Number of events 2 • 28 days

Other adverse events

Measure	Inhaled Nitric Oxide n=38 participants at risk Inhaled nitric oxide Nitric Oxide + oxygen	Sham n=38 participants at risk oxygen Nitrogen + Oxygen
Cardiac disorders arrhythmia	31.6% 12/38 • Number of events 12 • 28 days	28.9% 11/38 • Number of events 11 • 28 days

Additional Information

Jeffrey A. Kline, MD

Indiana University

Phone: 317-880-3900

Email: jefkline@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place